G/SPS/N/EU/552  
 
5 April 2022  
(22-2741) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Preparation of a kind used in animal nutrition  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Implementing Regulation  (EU) 2022/415 of 
11 March 2022 concerning the authorisation of malic acid, citric acid produced by  
Aspergillus niger  DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, 
sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, 
propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic 
acid, sodium formate, calcium formate and ammonium formate,  and lactic acid produced 
by Bacillus coagulans  (LMG S -26145 or DSM 23965), or Bacillus smithii  (LMG S -27890) or 
Bacillus subtilis  (LMG S -27889) and calcium lactate as feed additives for all animal species 
(Text with EEA relevance) . Language(s):  English, French and Spanish . Number of 
pages:  22 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_2467_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_2467_00_f.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_2467_00_s.pdf  
6. Description of content:  DL-malic acid, citric acid, sorbic acid and potassium sorbate, 
acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, 
calcium propionate and ammonium propionate, formic acid, sodium formate, calcium 
formate and ammonium formate, and lactic acid and calcium lactate were authorised 
without a time limit as feed additives for all animal species in accordance with 
Directive  70/524/ EEC. Those additives were subsequently entered in the Register of feed 
additives as existing products, in accordance with Article 10(1) of Regulation (EC) 
No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in 
conjunction with Ar ticle 7 thereof, applications were submitted for the re -evaluation of 
DL-malic acid, citric acid produced by Aspergillus niger  DSM 25794 or CGMCC 
4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic 
acid, sodium diacetate and  calcium acetate, propionic acid, sodium propionate, calcium 
propionate and ammonium propionate, formic acid, sodium formate, calcium formate and 
ammonium formate, and lactic acid produced by Bacillus coagulans  (LMG S -26145 or 
DSM 23965), Bacillus smithii  (LMG S -27890) or Bacillus subtilis  (LMG S -27889) and 
calcium lactate as feed additives for all animal species. The applicants requested those 
additives to be classified in the additive category 'technological additives' and in the 
functional group 'preserv atives' or 'acidity regulators'. The applications were accompanied 
by the particulars and documents required under Article 7(3) of Regulation (EC) G/SPS/N/EU/552  
 
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  No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its 
opinion of 29 January 201 4 that, under the proposed conditions of use, DL -malic acid does 
not have an adverse effect on animal health, consumer safety or the environment. It also 
concluded that the additive is irritant to skin, mucosae and eyes and the exposure via 
inhalation is a  risk. Therefore, the Commission considers that appropriate protective 
measures should be taken to prevent adverse effects on human health, in particular as 
regards the users of the additive. The Authority also concluded that it is effective as a feed 
preservative.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Code of practice on Good Animal Feeding 
CAC/RCP  54-2004 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international st andard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 11 March 2022 
Proposed date of publication (dd/mm/yy) : 14 March 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on the twentieth day following its 
publication in the Off icial Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29  98090  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/552  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if a vailable) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29  98090  
E-mail: sps@ec.europa.eu